FONT-SIZE Plus   Neg

European Commission Oks Novartis' Afinitor Tablets For Treatment Of HR+/HER2

Novartis International AG (NVS) said the European Commission has approved Afinitor (everolimus) tablets for treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

The approval was based on the Phase III BOLERO-2 trial. The randomized, double-blind, placebo-controlled, multi-center study of 724 patients found that treatment with Afinitor plus exemestane more than doubled median progression-free survival, or PFS, to 7.8 months, compared to 3.2 months with exemestane alone, by local investigator assessment.

Besides, an additional analysis based on an independent central radiology review showed Afinitor extended median PFS to 11.0 months compared to 4.1 months. The most common grade 3-4 adverse reactions were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis and diarrhea.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Retailers could see record web traffic this year as more consumers then ever before plan to shop online, according to Deloitte's 31st annual holiday survey of consumer spending intentions and trends. The survey found that holiday shoppers this year plan to spend just as much as online as they spend in brick and mortar stores. Oil giant Chevron Corp. on Friday reported a 37 percent decline in profit for the third quarter from last year, reflecting lower oil prices and weak refining margins. However, both revenue and earnings per share for the quarter beat analysts' estimates. In addition, the company raised its quarterly dividend. Mastercard Inc. (MA) reported a profit for the third quarter of 2016 that increased about 21 percent from the year-ago period, while it was up 15% excluding a special item related to the termination of the U.S. employee pension plan taken in last year's third quarter. Both earnings per share and revenue for the quarter beat analysts' expectations.
comments powered by Disqus
Follow RTT